US FDA warns Dr Reddy's Laboratories of ban if flaws are not fixed

US FDA may also withhold approval of new applications from Dr Reddy’s if it fails to complete all corrections, it said in a letter dated November 5.CR Sukumar | ET Bureau | November 26, 2015, 08:43 IST

HYDERABAD: The US Food and Drug Administration has threatened to ban all products made at certain facilities of Dr Reddy’s Laboratories, India’s second largest drugmaker, unless they conform to prescribed global manufacturing standards. The US regulator may also withhold approval of new applications from Dr Reddy’s if it fails to complete all corrections, it said in a letter dated November 5 that was posted on its website on Wednesday.

While making several critical observations pertaining to failures of Dr Reddy’s to contain recurrent violations, the FDA made it clear that it was not satisfied with nine responses submitted by the Indian drugmaker between December 2014 and September 2015.

The FDA said its inspection teams had "identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients" at Dr Reddy’s plants located at Srikakulam in Andhra Pradesh and Nalgonda in Telangana. The FDA teams "found significant violations of CGMP regulations for finished pharmaceuticals" at the company’s facility at Duvvada in Andhra Pradesh.

These violations and deviations pertain to failure to maintain complete data derived from laboratory tests, failure to prevent unauthorised access or changes to data, inadequate controls to prevent omission of data, failure to record activities, failure to adequately investigate out-of-specification results and failure to maintain quality related documents.

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